Medidata AMUG Meeting / Presentation 2013
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Transcript of Medidata AMUG Meeting / Presentation 2013
Having your Cake and Ea1ng it Too – Leveraging RWS with
Phase 1 Studies
Brock Heinz Spaulding Clinical March 19, 2013
About me and Spaulding Clinical Research • Brock Heinz - Engineering / Innovation; successfully demoted;
introduced to Medidata in 2009; Technology Partner
• Established in 2007 with a team of experts from pharmaceutical, CRO, clinical practice, and the medical device industries with over 150 years of combined experience; Located in West Bend, WI – 30 miles north of Milwaukee
• Highly integrated and automated phase I clinical pharmacology
research unit; 155 beds – 96 telemetry
• Data Management, Biostatistics and Medical Writing Services
• Full Service Core ECG Lab
• Medical Device Manufacturer
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Phase 1 trials at Spaulding Clinical • EDC true to the acronym: truly using electronic means for
data capture; not just electronic storage • Barcode-driven data collection – right subject each time • Integration of ECG, vitals, labs
• Rapid data lock is the rule, not the exception • Data cleaning is a dirty term • Sponsors always have real time access to study data • Basic philosophy I’ve helped instill – let computers do what
computers are good at, thus maximizing the human touch • Computers consistently do the right thing at the right time • Humans work well with humans – keep the peace with
subjects • Reducing variability is good science
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Phase 1 Trial – at a Glance
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What’s the Cake? • The cake in this context is a paperless and and automated
Phase 1 study seamlessly integrated with the sponsor’s EDC system of choice – Rave
Who’s Cake is it? • Sponsors who have a desire to maintain study data
throughout the lifecycle of a compound in Rave
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How can one have their cake and eat it too? Introducing SCi Rave (pronounced sky) • The customer is always right. Sponsors understand their data
structures and their processes, data standards come from the top down.
• Modular system consists of three major components
• Rave – where are we going? • ETL – how / what should we pack? • Interface Engine – how do we get there?
• Process Overview • Upload / parse loader file • Develop / validate ETL • Schedule and execute transfers
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Loader file driven design – begin with end in mind
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Data model – driven by Architect Loader
ETL – packing for the trip
• Extract, Transform, Load • Incredibly flexible model – layer of indirection can obtain data
from other EDC systems, relational databases, flat files, etc • Two primary tasks:
– Identify subjects – Query study repository(ies?) and populate tables created
by loader parsing process • Script is uploaded through our web interface and is compiled
and executed on the server • Validate ETL script!
– Pre-transferred data can be reviewed in Excel / CSV
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Let’s go! Scheduling and executing the transfer
• Transfer schedule is flexible – can be dictated by sponsor • Designate transfer schedule
– Automatic and near real-time – Ad hoc
• Transfer schedule set from web interface • Subjects inserted, form (Item Group) data sent • Each transaction response from RWS is stored with the Item
Group for which it was sent; available for review in web dashboard
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SCi Rave – system architecture
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Configuring system
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Validating ETL; ad hoc interaction
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RWS transactions
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Memories of a recent trip
• 3 studies conducted in rapid succession • 3,926 Folders • 18,803 Forms • 54,039 Item Groups (includes log lines) • 322,685 Items • 1,460,485 characters of time-point data • 78,796 HTTPS Requests to RWS • 0 CRFs manually transcribed from the Spaulding Clinical system
into Rave
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Final thoughts
I’ve been around web services for a while – this is well done: ODM, interoperable protocols, intuitive response messages, documentation, user group, etc. As leaders in EDC Medidata is refreshingly different than EMR vendors. What’s next? • I think we’ll seen see an evolution of drug development
process. There will be disruption as there is a push towards personalized medicine. Tighter iterations, richer data.
• Big Data – sensors; distributed telemetry; integrated data repositories. Mobile integration.
• Empower innovators – RWS gives us the highway needed. • Device level integration - today
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Spaulding webECGTM
• Hand-held diagnostic electrocardiograph uploads data to web-based ECG Management System
• Biometric voice ID eliminates demographic entry
errors
• Single button allows for malleable user interface
• Stores up to 5 minutes of 12-lead ECG data • Automated report available immediately
• Nearly instant over-reading
Model 1000iQ Electrocardiograph
Integrated data collection
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ECG document – demographics via RWS
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Automatic transcription
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Thank you!